SYS6043, a Subsidiary of CSPC Innovation, Initiates Phase III Clinical Trial

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CSPC Innovation Pharmaceutical's holding subsidiary, CSPC Megalith Biopharmaceutical, has initiated a Phase III clinical trial for SYS6043. The trial is a randomized, multicenter, open-label study designed to evaluate SYS6043 versus investigator's choice of chemotherapy in participants with platinum-resistant advanced ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. SYS6043 is a B7-H3-targeting antibody-drug conjugate. Its antibody component can specifically bind to and internalize into tumor cells, where it is cleaved by proteases to release a small-molecule toxin that kills tumor cells and exerts a bystander effect. Meanwhile, Fc engineering reduces lymphocyte uptake to lower the risk of off-target toxicity. Megalith Biopharmaceutical received the Phase III clinical trial approval notice from the National Medical Products Administration in July 2026, and subject recruitment and screening are now actively underway. The company also cautioned that drug development involves high investment, high risk, and long cycles, and products can only be marketed after review by the National Medical Products Administration, with no significant short-term impact on financial performance.

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石药集团巨石生物制药有限公司i
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As the holding subsidiary, it directly initiated the Phase III trial for SYS6043.

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